MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that aneurysm enlargement of 11.4mm and a type iiib endoleak of the distal afx2 main body complaints are confirmed.The additional endovascular procedure complaints are unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final was reported as discharged.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately four and a half (4.5) years post initial procedure, during a routine follow up, a computed tomography (ct) scan identified a suspected aneurysm enlargement.Approximately two (2) months after follow-up reintervention was performed.A type iiib endoleak was identified and the afx2 bifurcated stent graft was relined with a terumo (non-endologix) treo abdominal stent graft system.The final was reported as discharged.The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately four and a half (4.5) years post initial procedure, during a routine follow up, a computed tomography (ct) scan identified a suspected aneurysm enlargement.Approximately two (2) months after follow-up reintervention was performed.A type iiib endoleak was identified and the afx2 bifurcated stent graft was relined with a terumo (non-endologix) treo abdominal stent graft system.The final was reported as discharged.
Additional Manufacturer Narrative
Correction: a3: sex has been updated.G3: awareness date has been updated.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; irvine, CA 92618
• MDR Report Key: 20640018
• Report Number: 3011063223-2024-00161
• Device Sequence Number: 12604351
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)210111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2021
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2033476004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2266805003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male